General Information

Location: Remote, Washington, DC

Organization: Statistics Collaborative

Job Type: Full Time - Regular

Description and Requirements

The Director, Biostatistical Consulting will provide statistical oversight on multiple statistical consulting projects.  Projects may include program and trial design support, independent statistical oversight, and regulatory support.

EDUCATION REQUIREMENTS:

·       M.S. or equivalent degree in statistics, or related field; PhD preferred

VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

QUALIFICATIONS/EXPERIENCE:

·       At least ten (10) years of post-Master’s industry experience in clinical trials

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required.

  • Statistical consulting work related to program and trial design that may include due diligence support, Clinical Development Plan support, endpoint selection and statistical analysis planning, and clinical assessment development and validation.
  • Independent statistical oversight that may include cross-portfolio review of statistical analysis plans and study-level output, ensuring consistency and quality across the portfolio.
  • Regulatory support related to integrated safety and/or efficacy analyses, submission-level statistician oversight, submission review, mock FDA panels, and rapid response teams.
  • Assume major responsibilities for clients and for the client’s including the level of staffing required for the project and managing both its statistical and financial aspects.
  • Attend meetings of statistical societies, and present papers or posters at least every other year.
  • May serve as a peer reviewer of scientific manuscripts and proposals.
  • Remain abreast of current advances in biostatistics.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.

TRAVEL REQUIREMENTS: 0-5%


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